drugs

SPIRAMICINA MG ® Spiramycin

SPIRAMICINA MG ® is a drug based on spiramycin

THERAPEUTIC GROUP: Antibacterials - Antibiotics for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications SPIRAMICINA MG ® Spiramycin

SPIRAMICINA MG ® is an antibiotic used clinically in the treatment of infections caused by micro-organisms sensitive to Spiramycin generally responsible for infections of the respiratory tract, oral cavity, skin and soft tissues.

Mechanism of action SPIRAMYCINE MG ® Spiramycin

SPIRAMICINA MG ® is a generic drug based on Spiramycin, an active ingredient naturally extracted from Streptomyces Ambofaciens, known for its important bacteriostatic activity.

More precisely taken orally, it is rapidly absorbed at the intestinal level and immediately distributed among the various tissues where, interacting with the 50S ribosomal structures, it blocks protein synthesis preventing the enzyme peptidyltransferase from continuing with the lengthening of the peptide chain.

The effective bacteriostatic activity also in relation to Micoplasma Pneumoniae and Toxoplasma gondii, allows a regression of the symptomatology in only a few days of treatment, thus avoiding the onset of resistance mechanisms, sometimes present, able to significantly reduce the therapeutic efficacy, preventing the drug from reaching therapeutic concentrations in the target cells.

At the end of its activity, Spiramycin is eliminated mainly through bile, thus not further overloading kidney function.

Studies carried out and clinical efficacy

1 SPIRAMYCINE AND GRAVIDIC TOXOPLASMOSIS

Eur J Clin Microbiol Infect Dis. 2009 Mar; 28 (3): 297-300.

Study that evaluates the efficacy and safety of co-administration of Spiramycin and co-trimoxazole in controlling the maternal-fetal transmission of the infection supported by Toxoplasma Gondii, revealing itself to be useful and safe and reducing the risks of serious malformations.

2. THE USE OF SPIRAMICINA IN PREGNANCY

Br J Clin Pharmacol. 2006 Mar; 61 (3): 336-40.

As is known, Spiramycin is clinically used in the treatment of Toxoplasma infections in pregnancy to prevent the malformations associated with this infection. In this study it was observed that this therapy can reduce the hypertension associated with pregnancy, evidently involved in the genesis of the aforementioned malformations.

3. METHODS OF PRODUCTION OF THE SPIRAMICICIN

J Zhejiang Univ Sci. 2004 Jun; 5 (6): 689-95.

Technical work that researches new, safer and faster methods for the microbiological production of Spiramycin starting from Streptomyces Ambofaciens crops, in order to reduce costs while maintaining high quality standards.

Method of use and dosage

SPIRAMICINA MG ®

Film-coated tablets of 3 million IU Spiramycin.

Treatment for a few days with 3 million IU of spiramycin taken 2-3 times a day with plenty of water is generally effective and safe in most cases.

However, under certain conditions, such as pediatric or senile patients, it would be necessary to adapt the dosages used.

Warnings SPIRAMYCINE MG ® Spiramycin

Although the use of SPIRAMICINA MG ® is generally safe and well tolerated it is necessary that the intake of this drug is preceded by a careful medical examination in order to evaluate the prescriptive appropriateness, therefore also the absence of potentially incompatible conditions with the therapy based on Spiramycin.

Particular caution should in fact be reserved for patients suffering from liver and kidney diseases as well as an enzyme deficiency of glucose 6 phosphate dehydrogenase, responsible for anemic crises, sometimes even serious ones.

SPIRAMICINA MG ® contains lactose among its excipients, making it therefore contraindicated in patients with lactase enzyme deficiency, glucose galactose malabsorption syndrome and lactose intolerance.

PREGNANCY AND BREASTFEEDING

Although the use of spiramycin during pregnancy is generally safe and has no relevant clinical effects on the fetus, it would be advisable to avoid taking it during breastfeeding given the ability to concentrate in clinically significant quantities in breast milk.

Interactions

The simultaneous use of macrolides could enhance the therapeutic effect and the severity of the side effects of Spiramycin.

The literature also reports different case-reports of possible drug interactions, which however did not reach statistically significant values.

Contraindications SPIRAMICINA MG ® Spiramycin

SPIRAMICINA MG ® is contraindicated in patients who are hypersensitive to the active ingredient or to one of its excipients.

Undesirable effects - Side effects

As with any other antibiotic, especially prolonged use of SPIRAMICINA MG ® could cause nausea, diarrhea, vomiting, pseudomembranous colitis, headache, hypertransaminasemia and hypersensitivity reactions, especially dermatologic.

The risk of haemolysis is also reported in patients with enzyme deficiency of glucose 6 phosphate dehydrogenase undergoing Spiramycin therapy.

Note

SPIRAMYCINE MG ® is a prescription drug subject to mandatory medical treatment.